BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3130043 · Received May 24, 2013

    Report

    Report Number
    1823260-2013-03184
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH (B)(6) IS AVIVA SYSTEM 1, MEDWATCH WITH (B)(6) IS AVIVA SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM 1 BLOOD GLUCOSE RESULTS, ALL MG/DL: (B)(6) 2013 12:23PM 489 12:25PM 119 12:33PM 110 12:35PM 136 12:39PM 110 12:40PM 179 HE USED THE SAME VIAL OF STRIPS WITH AVIVA SYSTEM 2: (B)(6) 2013 1:31PM 157 1:31PM 111 1:33PM HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL 1:35PM 108 1:38PM 122 2:00PM 219 NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231282 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491645

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male AMANTADINE 2X A DAY| AMLODIPINE 1X A DAY| ASPIRIN 1X A DAY| ATENOLOL 1X A DAY| CARBIDOPA-LEVODOPA 8-9X A DAY| CETIRIZINE 1X A DAY| CITALOPRAM 1X A DAY| CPAP MACHINE| DICLOFENAC 1X A DAY| DIOVAN 1X A DAY| FUROSEMIDE 1X A DAY| HUMALOG 3X A DAY| LEVEMIR 1X A DAY| LIPITOR 1X A DAY| RAMIPRIL 2X A DAY| ROPINIROLE HCL 2X A DAY| ASPIRIN 1X A DAY| FUROSEMIDE 1X A DAY| LIPITOR 1X A DAY| AMLODIPINE 1X A DAY| DICLOFENAC 1X A DAY| CPAP MACHINE| CITALOPRAM 1X A DAY| ATENOLOL 1X A DAY| CETIRIZINE 1X A DAY| CARBIDOPA-LEVODOPA 8-9X A DAY| RAMIPRIL 2X A DAY| ROPINIROLE HCL 2X A DAY| DIOVAN 1X A DAY| HUMALOG 3X A DAY| LEVEMIR 1X A DAY| AMANTADINE 2X A DAY